🇪🇺 enfortumab vedotin (EV) in European Union

EMA authorised enfortumab vedotin (EV) on 13 April 2022

Marketing authorisation

EMA — authorised 13 April 2022

  • Application: EMEA/H/C/005392
  • Marketing authorisation holder: Astellas Pharma Europe B.V.
  • Local brand name: Padcev
  • Indication: Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.  Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.
  • Status: approved

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enfortumab vedotin (EV) in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is enfortumab vedotin (EV) approved in European Union?

Yes. EMA authorised it on 13 April 2022.

Who is the marketing authorisation holder for enfortumab vedotin (EV) in European Union?

Astellas Pharma Europe B.V. holds the EU marketing authorisation.